Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma
M.D. Anderson Cancer Center
Summary
To learn if sacituzumab tirumotecan can help to control advanced or metastatic SMARCB1-deficient RMC in patients whose disease has progressed after receiving at least 1 treatment.
Description
Primary Objectives To determine the objective response rate (ORR) at any time and disease control rate (DCR) through 18 weeks from treatment initiation, as assessed by independent reviewer per RECIST 1.1, of sacituzumab tirumotecan in participants with locally advanced or metastatic SMARCB1-deficient RMC who have progressed on at least one prior line of therapy. Secondary Objectives To determine the efficacy and safety of sacituzumab tirumotecan in participants with locally advanced or metastatic SMARCB1-deficient RMC who have progressed on at least one prior line of therapy. Efficacy will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible. 2. Participants will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ. 3. Participants must have at least one measurable site of disease, defined as a lesion t…
Interventions
- DrugSacituzumab tirumotecan
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas